Thorlacius Linnea, Esmann Solveig, Miller Iben, Vinding Gabrielle, Jemec Gregor B E
Department of Dermatology, Zealand University Hospital, Roskilde, Denmark.
Health Sciences Faculty, University of Copenhagen, Copenhagen, Denmark.
Skin Appendage Disord. 2019 Jun;5(4):221-229. doi: 10.1159/000496234. Epub 2019 Feb 14.
Hidradenitis suppurativa (HS) is a chronic and painful skin disease. In addition, HS lesions may be associated with pus and odour, potentially leading to significant stigma and, consequently, greatly affected quality of life (QOL). QOL is a multidimensional construct, which can be measured in various ways. However, generic or dermatologic QOL measures may not capture changes in QOL particularly affected in HS. Accordingly, patients and experts included in the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) agreed that future clinical HS trials should measure HS-specific QOL.
To develop an HS-specific QOL instrument (HiSQOL, Hidradenitis Suppurativa Quality of life).
The initial phases of the questionnaire development, described in this study, included item generation by patient interviews, development of a pilot questionnaire, questionnaire refinement, and pilot testing.
For item generation, 21 patients were interviewed individually or in focus groups. Analysis of the interviews identified 105 candidate items and, next, a pilot questionnaire was developed. Finally, item reduction and two rounds of pilot testing resulted in a 23-item questionnaire representing physical, psychological, and social QOL dimensions.
We have comprehensively explored on HS's possible effect on the QOL of the affected individuals and identified a 23-item HS-specific QOL questionnaire. The questionnaire proved to be feasible, acceptable, and comprehensible in the second round of pilot testing. With HiSQOL, researchers can measure HS-specific QOL in future clinical trials, potentially enabling them to discover more effective treatment options. It is envisaged, that after thorough validation in a trial setting, a streamlined version of HISQOL may also become available for clinical use in daily practice.
化脓性汗腺炎（HS）是一种慢性疼痛性皮肤病。此外，HS皮损可能伴有脓液和异味，这可能导致严重的污名化，进而极大地影响生活质量（QOL）。生活质量是一个多维度的概念，可以通过多种方式进行衡量。然而，通用的或皮肤科的生活质量测量方法可能无法捕捉到HS患者生活质量中受到特别影响的变化。因此，化脓性汗腺炎核心结局集国际协作组（HISTORIC）的患者和专家一致认为，未来的HS临床试验应测量特定于HS的生活质量。
开发一种特定于HS的生活质量工具（HiSQOL，化脓性汗腺炎生活质量量表）。
本研究中描述的问卷开发初始阶段包括通过患者访谈生成条目、编制预试验问卷、完善问卷以及预试验。
为了生成条目，对21名患者进行了单独访谈或焦点小组访谈。对访谈的分析确定了105个候选条目，接下来编制了预试验问卷。最后，通过条目删减和两轮预试验，形成了一份包含23个条目的问卷，代表身体、心理和社会生活质量维度。
我们全面探讨了HS对受影响个体生活质量的可能影响，并确定了一份包含23个条目的特定于HS的生活质量问卷。该问卷在第二轮预试验中被证明是可行、可接受且易于理解的。有了HiSQOL，研究人员可以在未来的临床试验中测量特定于HS的生活质量，这可能使他们能够发现更有效的治疗方案。预计在试验环境中经过充分验证后，HiSQOL的简化版本也可用于日常临床实践。
